Ocera Therapeutics Inc (NASDAQ:OCRX) announced the dosing of the first patients in Part Two of a Phase1/Phase 2a clinical trial of oral OCR-002 (ornithine phenylacetate). Oral OCR-002 is a validated ammonia scavenger in development for use as a step-down therapy and for chronic use to maintain remission of hepatic encephalopathy (HE), a neurocognitive disorder associated with serious liver disease.
The Phase 2a portion of the trial is an open-label, multiple-dose, randomized, 3-period crossover study. It is designed to evaluate the steady-state pharmacokinetics and pharmacodynamics of three times daily administration of three daily dose regimens, 6, 12 and 21 grams, of OCR-002 tablets in 18 patients with Child-Pugh1 B cirrhosis. We expect to complete the trial and report top-line results by the end of 2017.
“Advancing oral OCR-002 into Phase 2a marks another significant milestone in the progression of our pipeline and programs for orphan and other serious liver diseases,” said Linda Grais, Chief Executive Officer of Ocera.
“Patients with cirrhosis continue to have significant breakthrough episodes of HE, even with current standard of care for HE prevention. We are developing an oral formulation to address this need. Our initial focus will be as a step-down therapy for patients following hospitalization for an acute episode of overt HE, in order to prevent re-hospitalization and relapse of HE.”
Shares of Ocera are up 6.5% to $1.15 in pre-market trading Thursday. OCRX has a 1-year high of $3.15 and a 1-year low of $0.52. The stock’s 50-day moving average is $1.23 and its 200-day moving average is $1.49.
Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company. It engages in development and commercialization of OCR-002 (ornithine phenylacetate0 in intravenous and oral formulations.